Regulatory Submissions Specialist

Scorpion Therapeutics; New Haven (CT); On-site; USD 80,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regulatory Submissions Specialist to prepare, process, and submit regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies.

The role focuses on electronic publishing, quality checks, and publishing workflows using eCTD Manager, Adobe Acrobat, and Veeva RIMS, ensuring compliance with regional regulations while supporting global submissions.

Qualifications

• Experience in regulatory submissions and electronic publishing for IND/CTA/BLA filings.
• Familiarity with eCTD format and ESG submission standards.
• Proficiency in MS Word and EndNote for document preparation.

Responsibilities

• Assemble regulatory submissions and format documents.
• Quality check and publish submissions using publishing tools.
• Archive submissions and ensure regulatory compliance across regions.
• Provide regulatory guidance on documentation and troubleshoot system issues.

Skills

Regulatory submissions

Electronic publishing

Attention to detail

Analytical skills

Multitasking

Tools

MS Word

EndNote

eCTD ESG submission tools

Job description

Role

Regulatory Submissions Specialist responsible for preparing, processing, and submitting regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies.

Responsibilities

• assemble
• format
• quality check
• publish
• archive submissions using electronic publishing tools (eCTD Manager, Adobe Acrobat, Veeva RIMS)
• ensure compliance with regional regulations
• provide regulatory guidance on documentation
• troubleshoot system issues
• and optimize submission workflows.

Requirements

• minimum 1 year of regulatory electronic publishing experience
• familiarity with IND, CTA, BLA submissions
• eCTD and ESG electronic submission experience
• proficiency in MS Word and EndNotes
• strong attention to detail
• analytical skills
• and ability to manage multiple tasks in a fast-paced environment.

Preferred

• experience with clinical trial documentation and validation of publishing systems.

High-Value

• focus on electronic publishing for regulatory submissions
• experience with global health authority filings, including IMPDs and Briefing Documents
• knowledge of regulatory compliance and document control systems.

Work Setup

not specified.